Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
NCT ID: NCT06078709
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
99 participants
INTERVENTIONAL
2023-11-20
2026-11-30
Brief Summary
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Detailed Description
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I. To demonstrate non-inferiority of pathologic complete response (pCR) with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls.
SECONDARY OBJECTIVES:
I. Report targeted acute grade ≥ 3 gastrointestinal (GI) toxicity, per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
II. Assess post-operative toxicity for patients undergoing esophagectomy, as determined by the Clavien-Dindo Classification.
III. Analyze patient-reported quality of life, per Functional Assessment of Cancer Therapy- Esophageal (FACT-E).
IV. Determine the financial toxicity of hypofractionated radiotherapy, using Comprehensive Score for Financial Toxicity (COST-FACIT).
V. Report overall survival and progression-free survival. VI. Report long-term toxicity secondary to trimodality therapy. VII. Report event-free survival. VIII. Assess outcomes for patients treated with hypofractionated radiotherapy and FOLFOX but who did not proceed to esophagectomy.
IX. Compare toxicity of chemoradiation between patients receiving proton based versus (vs.) photon-based radiotherapy.
X. Compare clinical outcomes and pCR for patients receiving hypofractioned radiotherapy but different induction chemo (immuno) therapy regimens: no induction vs. fluorouracil, oxaliplatin, leucovorin, docetaxel (FLOT) vs. FLOT + durvalumab.
CORRELATIVE OBJECTIVES:
I. Explore the predictive and prognostic role for circulating tumor DNA in esophageal cancer.
II. Study the utility of whole exome and germline sequencing to predict chemoradiation treatment response.
III. Explore the predictive power of whole exome sequencing regarding chemoradiotherapy toxicity.
IV. Implement whole exome and germline sequencing to personalize immunotherapy in esophageal cancer.
V. Study the predictive and prognostic role of tumor-derived extracellular vesicles in esophageal cancer.
OUTLINE:
INDUCTION CHEMOTHERAPY: Patients receive 5-FU intravenously (IV) over 24 hours on day 1, leucovorin calcium IV over 10-120 minutes on day 1, oxaliplatin IV over 2-6 hours on day 1, and docetaxel IV over 1 hour on day 1 of each cycle. Treatment repeats every 2 weeks for a total of up to 6 cycles in the absence of disease progression or unacceptable toxicity. Eligible patients also receive durvalumab IV over 1 hour every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of FLOT, patients undergo radiation therapy daily for 3 weeks with 2 concurrent cycles of FOLFOX.
FOLFOX: Patients receive oxaliplatin IV over 2-6 hours on day 1, leucovorin calcium IV over 10-120 minutes on day 1, and and fluorouracil IV over 46-48 hours on days 1 and 2. of each cycle. Treatment repeats every 2 weeks for a total of 3 cycles in the absence of disease progression or unacceptable toxicity. Starting at cycle 2, patients undergo radiation therapy daily on Monday through Friday for a total of 15 treatments. Patients undergo esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS) during screening and undergo computed tomography (CT)/position emission tomography (PET) scan and CT scan as well as blood and tissue sample collection throughout the study.
After completion of study treatment, patients are followed up at 6,12 and 24 months and then up to 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (FLOT and Radiation and FOLFOX)
Patients received Induction Chemotherapy \[FLOT (5-FU/leucovorin/oxaliplatin/docetaxel)\] following by radiation therapy daily for 3 weeks with 2 concurrent cycles of FOLFOX per protocol. See detailed description for more information.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT scan
Endoscopic Ultrasound
Undergo EUS
Esophagogastroduodenoscopy
Undergo EGD
Fluorouracil
Given IV
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Leucovorin Calcium
Given IV
Oxaliplatin
Given IV
Positron Emission Tomography
Undergo PET and PET/CT scan
Survey Administration
Ancillary studies
Docetaxel
Given IV
Durvalumab
Given IV
Interventions
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Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT scan
Endoscopic Ultrasound
Undergo EUS
Esophagogastroduodenoscopy
Undergo EGD
Fluorouracil
Given IV
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Leucovorin Calcium
Given IV
Oxaliplatin
Given IV
Positron Emission Tomography
Undergo PET and PET/CT scan
Survey Administration
Ancillary studies
Docetaxel
Given IV
Durvalumab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological confirmation of esophageal or gastroesophageal junction adenocarcinoma, American Joint Committee on Cancer (AJCC) 8th edition stage T1-4N0-3M0
* Candidate for trimodality therapy: neoadjuvant chemo (immuno) therapy, chemoradiation, and esophagectomy
* Surgical consultation has confirmed that patient is an appropriate candidate for esophagectomy
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Negative pregnancy test done ≤ 7 days prior to chemotherapy, for women of childbearing potential only
* Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Willing to provide blood and tissue samples for correlative research purposes
Exclusion Criteria
* Cervical or upper esophageal tumor
* Prior chemotherapy or radiotherapy for esophageal cancer or history of radiotherapy to the thorax
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with proper assessment of adverse events
* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm or other active malignancy ≤ 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Christopher L. Hallemeier, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-07432
Identifier Type: REGISTRY
Identifier Source: secondary_id
GMROR2241
Identifier Type: OTHER
Identifier Source: secondary_id
23-001689
Identifier Type: OTHER
Identifier Source: secondary_id
GMROR2241
Identifier Type: -
Identifier Source: org_study_id
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